FI2629097T1 - NRF2 screening assays and related methods and compositions - Google Patents

NRF2 screening assays and related methods and compositions Download PDF

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Publication number
FI2629097T1
FI2629097T1 FIEP13156663.0T FI13156663T FI2629097T1 FI 2629097 T1 FI2629097 T1 FI 2629097T1 FI 13156663 T FI13156663 T FI 13156663T FI 2629097 T1 FI2629097 T1 FI 2629097T1
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fumarate
use according
administered
intended
monomethyl
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Finnish (fi)
Swedish (sv)
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Matvey Lukashev
Gilmore O'neill
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Biogen Idec Inc
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/502—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics for testing non-proliferative effects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225—Polycarboxylic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/275—Nitriles; Isonitriles
    • A61K31/277—Nitriles; Isonitriles having a ring, e.g. verapamil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4704—2-Quinolinones, e.g. carbostyril
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A61K38/217—IFN-gamma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/502—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics for testing non-proliferative effects
    • G01N33/5041—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics for testing non-proliferative effects involving analysis of members of signalling pathways
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/902—Oxidoreductases (1.)
    • G01N2333/90209—Oxidoreductases (1.) acting on NADH or NADPH (1.6), e.g. those with a heme protein as acceptor (1.6.2) (general), Cytochrome-b5 reductase (1.6.2.2) or NADPH-cytochrome P450 reductase (1.6.2.4)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/28—Neurological disorders
    • G01N2800/285—Demyelinating diseases; Multipel sclerosis

Claims (20)

PATENTTIVAATIMUKSETPATENT CLAIMS 1. Farmaseuttinen koostumus käytettäväksi mul- tippeliskleroosin hoidossa, joka koostumus koostuu: (a) dimetyylifumaraatista ja/tai monometyyli- fumaraatista, ja (b) yhdestä tai useammasta farmaseuttisesti hyväksyttävästä apuaineesta, jossa koostumus on tarkoitettu annettavaksi oraalisesti multippeliskleroosin hoitoa tarvitsevalle kohteelle, ja jossa annettavan dimetyylifumaraatin tai mono- metyylifumaraatin annos on noin 480 mg - noin 720 mg päivässä.1. A pharmaceutical composition for use in the treatment of multiple sclerosis, which composition consists of: (a) dimethyl fumarate and/or monomethyl fumarate, and (b) one or more pharmaceutically acceptable excipients, where the composition is intended to be administered orally to a subject in need of multiple sclerosis treatment, and where the administered the dose of dimethyl fumarate or mono-methyl fumarate is about 480 mg to about 720 mg per day. 2. Farmaseuttinen koostumus käytettäväksi pa- tenttivaatimuksen 1 mukaisesti, jossa koostumus koostuu dimetyylifumaraatista ja yhdestä tai useammasta farma- seuttisesti hyväksyttävästä apuaineesta.2. A pharmaceutical composition for use according to claim 1, wherein the composition consists of dimethyl fumarate and one or more pharmaceutically acceptable excipients. 3. Farmaseuttinen koostumus käytettäväksi pa- tenttivaatimuksen 1 mukaisesti, jossa koostumus koostuu monometyylifumaraatista ja yhdestä tai useammasta far- maseuttisesti hyväksyttävästä apuaineesta.3. A pharmaceutical composition for use according to claim 1, wherein the composition consists of monomethyl fumarate and one or more pharmaceutically acceptable excipients. 4. Farmaseuttinen koostumus käytettäväksi jon- kin patenttivaatimuksista 1 - 3 mukaisesti, jossa an- nettavan dimetyylifumaraatin tai monometyylifumaraatin annos on noin 480 mg päivässä.4. A pharmaceutical composition for use according to one of claims 1 to 3, wherein the dose of dimethyl fumarate or monomethyl fumarate to be administered is approximately 480 mg per day. 5. Farmaseuttinen koostumus käytettäväksi jon- kin patenttivaatimuksista 1 — 4 mukaisesti, jossa koos- tumus on tarkoitettu annettavaksi tabletin, suspension tai kapselin muodossa.5. A pharmaceutical composition for use according to one of claims 1 to 4, where the composition is intended to be administered in the form of a tablet, suspension or capsule. 6. Farmaseuttinen koostumus käytettäväksi jon- kin patenttivaatimuksista 1 — 5 mukaisesti, jossa dime- tyylifumaraatti ja/tai monometyylifumaraatti on tarkoi- tettu annettavaksi 2, 3, 4 tai 6 yhtä suuren annoksen erillisinä antokertoina.6. Pharmaceutical composition for use according to one of claims 1 to 5, where dimethyl fumarate and/or monomethyl fumarate is intended to be administered in 2, 3, 4 or 6 separate administrations of an equal dose. 7. Farmaseuttinen koostumus käytettäväksi pa- tenttivaatimuksen 6 mukaisesti, jossa dimetyylifumaraa- tin tai monometyylifumaraatin annos on tarkoitettu annettavaksi 2 yhtä suuren annoksen erillisinä antoker- toina.7. Pharmaceutical composition for use according to claim 6, wherein the dose of dimethyl fumarate or monomethyl fumarate is intended to be given in 2 separate doses of equal doses. 8. Farmaseuttinen koostumus käytettäväksi pa- tenttivaatimuksen 6 mukaisesti, jossa dimetyylifumaraa- tin tai monometyylifumaraatin annos on tarkoitettu an- nettavaksi 3 yhtä suuren annoksen erillisinä antoker- toina.8. A pharmaceutical composition for use according to claim 6, wherein the dose of dimethyl fumarate or monomethyl fumarate is intended to be administered in 3 separate administrations of an equal dose. 9. Farmaseuttinen koostumus käytettäväksi jon- kin patenttivaatimuksista 1 — 8 mukaisesti, jossa koos- tumus on tarkoitettu annettavaksi kohteelle 5, 10, 12, 20, 40, 52, 100 tai 200 viikon ajan tai pidempään.9. A pharmaceutical composition for use according to one of claims 1 to 8, wherein the composition is intended to be administered to a subject for 5, 10, 12, 20, 40, 52, 100 or 200 weeks or longer. 10. Farmaseuttinen koostumus käytettäväksi jonkin patenttivaatimuksista 1 - 9 mukaisesti, jossa koostumus on tarkoitettu annettavaksi kohteelle vähin- tään 12 viikon ajan.10. Pharmaceutical composition for use according to one of claims 1 to 9, where the composition is intended to be administered to the subject for at least 12 weeks. 11. Dimetyylifumaraatti tai monometyylifuma- raatti käytettäväksi multippeliskleroosin hoidossa, jossa dimetyylifumaraatti tai monometyylifumaraatti on ainoa annettava neuroprotektiivinen yhdiste ja jossa dimetyylifumaraatti tai monometyylifumaraatti on tar- koitettu annettavaksi oraalisesti multippeliskleroosin hoitoa tarvitsevalle kohteelle annoksena, joka on noin 480 mg — noin 720 mg päivässä.11. Dimethyl fumarate or monomethyl fumarate for use in the treatment of multiple sclerosis, where dimethyl fumarate or monomethyl fumarate is the only neuroprotective compound to be administered, and where the dimethyl fumarate or monomethyl fumarate is intended to be administered orally to a subject in need of multiple sclerosis treatment in a dose of about 480 mg — about 720 mg per day. 12. Dimetyylifumaraatti käytettäväksi patent- tivaatimuksen 11 mukaisesti, jossa dimetyylifumaraatti on ainoa annettava neuroprotektiivinen yhdiste.12. Dimethyl fumarate for use according to claim 11, wherein dimethyl fumarate is the only neuroprotective compound to be administered. 13. Monometyylifumaraatti käytettäväksi pa- tenttivaatimuksen 11 mukaisesti, jossa monometyylifuma- raatti on ainoa annettava neuroprotektiivinen yhdiste.13. Monomethyl fumarate for use according to claim 11, wherein monomethyl fumarate is the only neuroprotective compound to be administered. 14. Dimetyylifumaraatti tai monometyylifuma- raatti käytettäväksi jonkin patenttivaatimuksista 11 - 13 mukaisesti, jossa annos on noin 480 mg päivässä.14. Dimethyl fumarate or monomethyl fumarate for use according to one of claims 11 to 13, where the dose is about 480 mg per day. 15. Dimetyylifumaraatti tai monometyylifuma- raatti käytettäväksi jonkin patenttivaatimuksista 11 - 14 mukaisesti, jossa dimetyylifumaraatti tai monometyy- lifumaraatti on tarkoitettu annettavaksi tabletin, sus- pension tai kapselin muodossa.15. Dimethyl fumarate or monomethyl fumarate for use according to one of claims 11 to 14, where the dimethyl fumarate or monomethyl fumarate is intended to be administered in the form of a tablet, suspension or capsule. 16. Dimetyylifumaraatti tai monometyylifuma- raatti käytettäväksi jonkin patenttivaatimuksista 11 - 15 mukaisesti, jossa annos on tarkoitettu annettavaksi 2, 3, 4 tai 6 yhtä suuren annoksen erillisinä antoker- toina.16. Dimethyl fumarate or monomethyl fumarate for use according to one of claims 11 to 15, where the dose is intended to be given in 2, 3, 4 or 6 separate administrations of an equal dose. 17. Dimetyylifumaraatti tai monometyylifuma- raatti käytettäväksi patenttivaatimuksen 16 mukaisesti, jossa annos on tarkoitettu annettavaksi 2 yhtä suuren annoksen erillisinä antokertoina.17. Dimethyl fumarate or monomethyl fumarate for use according to claim 16, where the dose is intended to be given in 2 separate administrations of an equal dose. 18. Dimetyylifumaraatti tai monometyylifuma- raatti käytettäväksi patenttivaatimuksen 16 mukaisesti, jossa annos on tarkoitettu annettavaksi 3 yhtä suuren annoksen erillisinä antokertoina.18. Dimethyl fumarate or monomethyl fumarate for use according to claim 16, where the dose is intended to be given in 3 separate doses of equal doses. 19. Dimetyylifumaraatti tai monometyylifuma- raatti käytettäväksi jonkin patenttivaatimuksista 11 - 18 mukaisesti, jossa dimetyylifumaraatti tai monometyy- lifumaraatti on tarkoitettu annettavaksi kohteelle 5, 10, 12, 20, 40, 52, 100 tai 200 viikon ajan tai pidem- pään.19. Dimethyl fumarate or monomethyl fumarate for use according to one of claims 11 to 18, where the dimethyl fumarate or monomethyl fumarate is intended to be administered to the subject for 5, 10, 12, 20, 40, 52, 100 or 200 weeks or longer. 20. Dimetyylifumaraatti tai monometyylifuma- raatti käytettäväksi jonkin patenttivaatimuksista 11 - 19 mukaisesti, jossa dimetyylifumaraatti tai monometyy- lifumaraatti on tarkoitettu annettavaksi kohteelle vä- hintään 12 viikon ajan.20. Dimethyl fumarate or monomethyl fumarate for use according to one of claims 11 to 19, where the dimethyl fumarate or monomethyl fumarate is intended to be administered to the subject for at least 12 weeks.
FIEP13156663.0T 2007-02-08 2008-02-07 NRF2 screening assays and related methods and compositions FI2629097T1 (en)

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